Totally 34 FSMP Approved in China with a Boom of Nutritionally Complete Food

The State Administration for Market Regulation (SAMR) has approved the registration applications of 10 FSMP products from June 13 to July 5, 2019. Among them, there are 6 nutritionally complete food, the detailed information are shown in the table below:

S.N.

Applicant

Product Name

Acceptance Number

Issuing Date

1

Nestle Health Science China

佳膳佳立畅nutritionally complete food for special medical purpose

国食注申TY20180009

2019.6.13

2

SYNUTRA INTERNATIONAL INC

优博启能infant nutrition supplement for special medical purpose

国食注申TY20170087

2019.6.24

3

Nestlé Suisse SA, factory Konolfingen

小佰太能nutritionally complete food for special medical purpose

国食注申TY20180042

4

Du’erbote Yili Dairy Co. LTD

焕初nutritionally complete food (powder) for special medical purpose

国食注申TY20170055

2019.6.27

5

HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.

贝新尔preterm/low birth weight infant formula for special medical purpose

国食注申TY20170073

6

ABBOTT MANUFACTURING SINGAPORE PRIVATE LIMITED

ENSURE COMPLETE® nutritionally complete food for special medical purpose

国食注申TY20190001

2019.7.1

7

Nestlé Suisse SA, factory Konolfingen

NUTREN JUNIOR nutritionally complete food for special medical purpose

国食注申TY20180026

8

Nestlé Suisse SA, factory Konolfingen

NUTREN OPTIMUM nutritionally complete food for special medical purpose

国食注申TY20180027

9

Maeil Dairies Co., Ltd

爱思诺赋儿嘉infant lactose free formula for special medical purpose

国食注申TY20180036

2019.7.5

10

Maeil Dairies Co., Ltd

爱思诺晨而慧preterm/low birth weight infant formula for special medical purpose

国食注申TY20180035

Due to the institutional reform, the website of the former CFDA and of the SAMR are still in the process of data migration and construction. Up to July 8, 2019, only the specific information of the three products released on July 1st have been published in the website of the former CFDA, while the other seven are still being edited. Therefore, the registration certificate number and registration expiry date of them are marked with "-" in the following table (table 1), and the relevant information will be made up after being publicized on the website of the former CFDA or of the SAMR.

Summary and Analysis of the Approved FSMP in China

Up to now, totally 34 FSMP products have been approved in China. Among them, eight products are domestic products while the remaining are foreign products. It is worth to be mentioned that, the products issued on July 5, 2019 are produced by a Korean company -- Maeil Dairies Co., Ltd, which is the first time that the Asia products are successfully registered in China. Relevant information are listed as below in table 1:

Table 1. The 34 approved FSMP products

S.N.

Applicant

Product name

Certificate number

Expiry date

1

SHS INTERNATIONAL LTD

Neocate infant amino acid formula (powder) for special medical purpose

国食注字TY20175001

2022.11.19

2

ABBOTT LABORATORIES S.A.

Similac infant partially hydrolyzed milk protein formula (powder) for special medical purpose

国食注字TY20175002

2022.11.19

3

ABBOTT LABORATORIES S.A.

Eleva Care infant partially hydrolyzed milk protein formula (powder) for special medical purpose

国食注字TY20175003

2022.11.19

4

HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.

Beingmate infant lactose free formula for special medical purpose

国食注字TY20180001

2023.2.12

5

SHS INTERNATIONAL LTD

Periflex infant phenylketonuria formula (powder) for special medical purpose

国食注字TY20185001

2023.2.26

6

MEAD JOHNSON B.V.

EnfaGentlease infant partially hydrolyzed milk protein formula (powder) for special medical purpose

国食注字TY20185002

2023.3.19

7

ABBOTT NUTRITION, ABBOTT LABORATORIES

Similac Neo preterm/low birth weight infant formula for special medical purpose

国食注字TY20185003

2023.6.25

8

ABBOTT NUTRITION, ABBOTT LABORATORIES

Similac Gro preterm/low birth weight infant formula for special medical purpose

国食注字TY20185004

2023.6.25

9

MEAD JOHNSON B.V.

Enfagrow infant lactose free formula (powder) for special medical purpose

国食注字TY20185005

2023.7.22

10

NESTLE NEDERLAND B.V.

早瑞能恩 preterm/low birth weight infant formula for special medical purpose

国食注字TY20185006

2023.7.22

11

SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD

舒乐加 electrolyte formula for special medical purpose

国食注字TY20180002

2023.7.22

12

SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD

乐棠electrolyte formula for special medical purpose

国食注字TY20180003

2023.7.22

13

ABBOTT MANUFACTURING SINGAPORE PRIVATE LIMITED

Pediasure nutritionally complete food for special medical purpose

国食注字TY20185007

2023.8.2

14

MEAD JOHNSON B.V.

Enfapro preterm/low birth weight infant formula (powder) for special medical purpose

国食注字TY20185008

2023.8.13

15

SYNUTRA INTERNATIONAL INC

优博敏佳partially hydrolyzed milk protein formula for special medical purpose

国食注字TY20180004

2023.8.13

16

SYNUTRA INTERNATIONAL INC

优博安能preterm/low birth weight infant formula for special medical purpose

国食注字TY20180005

2023.8.13

17

ABBOTT LABORATORIES S.A.

ABBOTT Similac preterm/low birth weight infant formula (powder) for special medical purpose

国食注字TY20185009

2023.10.7

18

MILUPA GMBH

Nutricia preterm/low birth weight infant formula for special medical purpose

国食注字TY20185010

2023.10.7

19

SHS INTERNATIONAL LTD

Periflex Ad. phenylketonuria formula (powder) for special medical purpose

国食注字TY20185011

2023.12.19

20

NESTLE NEDERLAND B.V.

ALFARE infant extensively hydrolyzed milk protein formula for special medical purpose

国食注字TY20185012

2023.12.19

21

ABBOTT NUTRITION

Similac HMFortifi infant nutrition supplement for special medical purpose

国食注字TY20185013

2023.12.19

22

Nestlé Deutschland AG

早启能恩 preterm/low birth weight infant formula for special medical purpose

国食注字TY20195001

2024.01.23

23

Nestlé Deutschland AG

NAN H.A. partially hydrolyzed milk protein formula for special medical purpose

国食注字TY20195002

2024.01.23

24

NESTLE NEDERLAND B.V.

安儿宁能恩 infant lactose free formula for special medical purpose

国食注字TY20195003

2024.01.23

25

Nestle Health Science China

佳膳佳立畅nutritionally complete food for special medical purpose

-

-

26

SYNUTRA INTERNATIONAL INC

优博启能infant nutrition supplement for special medical purpose

-

-

27

Nestlé Suisse SA, factory Konolfingen

小佰太能nutritionally complete food for special medical purpose

-

-

28

Du’erbote Yili Dairy Co. LTD

焕初nutritionally complete food (powder) for special medical purpose

-

-

29

HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.

贝新尔preterm/low birth weight infant formula for special medical purpose

-

-

30

ABBOTT MANUFACTURING SINGAPORE PRIVATE LIMITED

ENSURE COMPLETE® nutritionally complete food for special medical purpose

国食注字TY20195005

2024.6.26

31

Nestlé Suisse SA, factory Konolfingen

NUTREN JUNIOR nutritionally complete food for special medical purpose

国食注字TY20195006

2024.6.26

32

Nestlé Suisse SA, factory Konolfingen

NUTREN OPTIMUM nutritionally complete food for special medical purpose

国食注字TY20195007

2024.6.26

33

Maeil Dairies Co., Ltd

爱思诺赋儿嘉infant lactose free formula for special medical purpose

-

-

34

Maeil Dairies Co., Ltd

爱思诺晨而慧preterm/low birth weight infant formula for special medical purpose

-

-

Note: the general names in the table are updated according to the Notice on the Adjustment of General Name of FSMP

There are totally 10 companies obtaining FSMP registration certificates, while among the 34 products, 9 of them have been developed by one company – Nestle. Moreover, with the launch of a product from Yili Group, there are 4 domestic companies obtaining certificates, the others are -- HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD, SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD and SYNUTRA INTERNATIONAL INC.

Food,China,Registration,Special,Medical,Purpose,Formula

Figure 1. Quantity of approved FSMP products at different companies

Among the 34 products, in terms of product type, 24 of them are infant formula for special medical purposes, 3 are nutritionally incomplete food, and 7 are nutritionally complete food. While specific nutritionally complete food have not been approved until now. The detailed information are shown in table 2.

Table 2. Summary of the categories/types of the approved products

Categories/types

Amount being approved

Product/Company

Adapted population

FSMP for infants under the age of 12 months 

Extensively hydrolyzed milk protein formula or amino acid-based formula food

2

Neocate / SHS

ALFARE/ NESTLE

0-12 months

Partially hydrolyzed milk protein formula food

5

Eleva Care / ABBOTT

Similac / ABBOTT

EnfaGentlease / MEAD JOHNSON

优博敏佳/ SYNUTRA

NAN H.A./Nestle

0-12 months

Lactose free formula or low lactose formula food

4

Beingmate / HANGZHOU BEINGMATE

Enfagrow / MEAD JOHNSON

安儿宁能恩/ Nestle

爱思诺赋儿嘉/ Maeil Dairies

0-12 months

Amino acid metabolism disorder formula food

1

Periflex / SHS

0-12 months

Premature or low birth weight infant formula food

10

Similac Neo / ABBOTT

Similac Gro / ABBOTT

早瑞能恩/ NESTLE

Enfapro/ MEAD JOHNSON

优博安能/ SYNUTRA

Similac/ ABBOTT

Nutricia/ MILUPA

早启能恩/ Nestle

爱思诺晨而慧/ Maeil Dairies

贝新尔/ HANGZHOU BEINGMATE

0-12 months

Infant nutrition supplement

2

Similac HMFortifi/ ABBOTT

优博启能/ SYNUTRA

0-12 months

FSMP for people over the age of 12 months

Nutritionally complete foods

7

Pediasure / ABBOTT

佳膳佳立畅/Nestle

小佰太能/Nestle

焕初/Yili Group

ENSURE COMPLETE®/Abbott

NUTREN JUNIOR /Nestle

NUTREN OPTIMUM /Nestle

1-10 year-old or above 10 years old

Specific nutritionally complete foods

0

NA

NA

Nutritionally incomplete foods

Electrolyte formula

2

舒乐加/ SUZHOU HENGRUI JIANKANG

Above 10 year-old

乐棠/ SUZHOU HENGRUI JIANKANG

Above 18 year-old

Nutrient components

0

NA

NA

Thickening components

0

NA

NA

Liquid formula

0

NA

NA

Amino acid metabolism disorder formula

1

Periflex Ad./SHS

Above 10 year-old

The above information are analysis associated with the current situation of FSMP registration in China. Click to know more about FSMP registration requirements in China.

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